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PTX3-targeted Antifungal Prophylaxis

RecruitingNAAges 18 Years - anyAllBochud Pierre-Yves
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In plain words

What the trial is, and whether it could suit you

This is a prospective genetically-stratified randomized double-blind event-driven multicentre clinical trial to assess the efficacy of posaconazole-based antifungal prophylaxis allocation strategies for patients with acute myeloid leukemia who receive induction chemotherapy. Allocation strategy based on an invasive mold infection genetic risk will be double-blinded.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Signed Informed Consent according to national/local regulations. 2. Age โ‰ฅ18 years. 3. Diagnosis of Acute Myeloid Leukemia (AML) or Myelodysplastic Syndrome in transformation (MDSit) treated with an intensive chemotherapy regimen, including induction / consolidation / salvage remission chemotherapy. 4. Planned hospital admission for the duration of the neutropenic phase (absolute neutrophils count \<500 cells/mm3). Exclusion Criteria: 1. Patients with neutropenia (absolute neutrophils count\<500 cells/mm3) upon presentation and prior to chemotherapy initiation. 2. Patients with a diagnosis of acute promyelocytic leukemia (APL) or AML-M3. 3. Patients with known history of allergy, hypersensitivity or serious reaction to azole antifungals 4. Women who are pregnant (positive blood/urine pregnancy test within 10 days before randomization) or breast-feeding. 5. Diagnosis and treatment for an Invasive Fungal Infection (IFI) within 3 months prior to study enrolment and an Invasive Mold Infection (IMI) at any point prior to or at the time of enrolment. 6. Severe liver dysfunction, defined as at least one of the following markers: Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT) or alkaline phosphatase above \>5x upper limit of normality: and/or total bilirubin above \>3x upper limit of normality. 7. Patients with an ECG with a prolonged QTc interval: QTc greater than 450 msec for men and greater than 470 msec for women. 8. Patients who are receiving and cannot discontinue the following drugs at least 24 hours prior to randomization: terfenadine, astemizole, cisapride, pimozide, halofantrine or quinidine (because of the possibility of QT prolongation), sirolimus, rifampin, rifabutin, carbamazepine, long-acting barbiturates (e.g., phenobarbital, mephobarbital), ritonavir, efavirenz, or ergot alkaloids (e.g., ergotamine, dihydroergotamine). 9. Serious uncontrolled concomitant disease or comorbidity that, in the opinion of the investigator, may compromise adherence to the study protocol. 10. Receipt of a prior allogeneic Hematopoietic Cell Transplantation (HCT). 11. Previous exposure to mold-active prophylaxis (\>48 hours within 7 days of inclusion). 12. Patients with relapsed leukemia already included in the trial. 13. Patient not affiliated to the French social security system 14. Patient under legal protection (guardianship, curatorship)
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What it tests

  • Posaconazole
  • Fluconazole
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Where

9 sites
Ghent University Hospital
Ghent, Belgium
AZ Sint-Jan Hospital
Bruges, Belgium
University Hospital Leuven (UZ Leuven)
Leuven, Belgium
Henri Mondor Hospital
Crรฉteil, France
Cantonal Hospital Aarau
Aarau, Switzerland
University Hospital Basel
Basel, Switzerland
Cantonal Hospital HFR
Fribourg, Switzerland
University Hospital of Geneva (HUG)
Geneva, Switzerland

โ€ฆand 1 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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